Institutional review board barriers and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now Study: a national multicenter practice-based implementation trial.

STUDY OBJECTIVE: To categorize institutional review board (IRB) challenges and solutions encountered in a multicenter practice-based research network (PBRN) study and to assess the impact of IRB requirements on the willingness of individual principal investigators (PIs) to participate in future PBRN studies. DESIGN: Descriptive analysis of IRB challenges and solutions encountered in the Collaboration Among Pharmacists and Physicians to Improve Outcomes Now (CAPTION) trial, a multicenter prospective cluster-randomized study conducted by the National Interdisciplinary Primary Care PBRN, and a correlational analysis from a survey of individual site PIs. MEASUREMENTS AND MAIN RESULTS: IRB barriers encountered and solutions were categorized for study sites. A survey of study-site PIs was conducted with a correlational analysis assessing the impact of various IRB requirements and the willingness of individual PIs to participate in future PBRN studies; of 31 study sites participating in the CAPTION study, 28 study-site PIs were surveyed. IRBs posed a number of challenges including bias regarding the source of the application, issues regarding study design, study instruments, access to patient records, study procedures, Spanish-only speaking subjects, role of clinic physicians, interdepartmental concerns, and updates at continuing review. Responses from the PI survey (21 of 28 PIs surveyed [75% response rate]) indicated that the willingness of an individual to serve as a PI in the future was inversely related to the perceived difficulty of obtaining initial (rS  = -0.599, p=0.004) and continuing (rS  = -0.464, p=0.034) IRB approval. CONCLUSION: Significant time and resources were required to address various challenges associated with IRB approval, which had a negative impact on an individual PI's willingness to participate in future PBRN projects. A revision of current rules and regulations regarding the protection of human subjects for practice-based studies, improvement in IRB processes, and support from coordinating centers may decrease the burden associated with IRB approval and increase participation in practice-based research.

Health information technology and physicians' knowledge of drug costs.

OBJECTIVE: To examine whether physicians' use of information technology (IT) was associated with better knowledge of drug costs. STUDY DESIGN/METHODS: A 2007 statewide survey of 247 primary care physicians in Hawaii regarding IT use and self-reported knowledge of formularies, copayments, and retail prices. RESULTS: Approximately 8 in 10 physicians regularly used IT in clinical care: 60% Internet, 54% e-prescribing, 43% electronic health records (EHRs), and 37% personal digital assistants (PDAs). However, fewer than 1 in 5 often knew drug costs when prescribing, and more than 90% said lack of knowledge of formularies and copayments remained a barrier to considering drug costs for patients. In multivariate analyses adjusting for sex, practice size, years in practice, number of formularies, and use of clinical resources (eg, pharmacists), use of the Internet -- but not e-prescribing, EHRs, or PDAs -- was associated with physicians reporting slightly better knowledge of copayments (adjusted predicted percentage of 23% vs 11%; P = .04). No type of IT was associated with better knowledge of formularies or retail prices. CONCLUSIONS: Despite high rates of IT use, there was only a modest association between physicians' use of IT and better knowledge of drug costs. Future investments in health IT should consider how IT design can be improved to make it easier for physicians to access cost information at the point of care.

Stratifying medical and pharmaceutical administrative claims as a method to identify pediatric asthma patients in a Medicaid managed care organization.

Claims data are a problematic indicator of underlying clinical diagnosis. They are attractive because of their affordability, a criterion especially salient in resource-shy environments such as the Medicaid Managed Care Organization. This study tested the validity of administrative medical and pharmaceutical claims stratified by treatment modality to identify true pediatric asthma patients. Primary and secondary data were used. Secondary data consisted of 1997 medical and pharmaceutical claims. Primary data consisted of chart data collected through expert chart review. We stratified claims by treatment modality hypothesized to better identify true asthma patients. Claim patterns were analyzed for support of expectations. Expert chart review determined true asthma status on study sample. We found that claims are patterned in accordance with hypotheses about stratification groups. The combined use of both medical and pharmaceutical claims was more effective in identifying asthmatics than the use of either set of claims by itself. The Medicaid Managed Care Organization can begin to identify its asthma population using the stratification meth.